NCT03590275

Brief Summary

The aim of this study is to identify new prognostic factors in patients affected by advanced pancreatic carcinoma treated with first line chemotherapy with FOLFIRINOX regimen. Primary objective is the identification of clinical, laboratory and pathologic factors affecting overall survival of these patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
343

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

4 months

First QC Date

July 6, 2018

Last Update Submit

July 6, 2018

Conditions

Pancreatic Cancer Non-resectable

Keywords

pancreatic cancerchemotherapyFOLFIRINOXprognostic

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Overall survival is defined as the time from study entry until death from any cause. Patients who are alive at the end of the study will be censored at that point.

    up to 2 years

Secondary Outcomes (3)

  • Progression-free survival

    up to 2 years

  • Response rate

    up to 2 years

  • Toxicity rate

    up to 2 years

Interventions

FOLFIRINOXDRUG

Patients treated with first-line FOLFIRINOX (oxaliplatin + irinotecan + lederfolin + 5-fluorouracil) as per clinical practice were included in the study

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with unresectable advanced pancreatic carcinoma treated with FOLFIRINOX at the involved institutions between 2010 and 2017 will be included.

You may qualify if:

  • age \>18 years
  • citologically or histologically confirmed pancreatic carcinoma
  • disease stage III or IV according to the American Joint Committee on Cancer (AJCC) staging system
  • access to clinical informations collected before first-line starting
  • availability of objective response evaluation and survival data
  • written informed consent

You may not qualify if:

  • diagnosis of other neoplasia than pancreatic carcinoma
  • treatment with drugs other than FOLFIRINOX
  • treatment with experimental drugs in combination with FOLFIRINOX
  • unavailability of clinical and pathological data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Oncologia ASL BI

Ponderano, Biella, 13875, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

Meldola, Forlì Cesena, 47014, Italy

Location

Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia FPO - IRCSS

Candiolo, Torino, 10060, Italy

Location

ASL VCO, Ospedale Castelli Verbania

Verbania, Torino, 28922, Italy

Location

A.O. Universitaria Pisana - Pisa (Pi) Oncologia Medica

Pisa, 56012, Italy

Location

P.O. Molinette Oncologia 1

Torino, 10126, Italy

Location

A.O. Ordine Mauriziano

Torino, 10128, Italy

Location

Related Publications (1)

  • Fornaro L, Leone F, Vienot A, Casadei-Gardini A, Vivaldi C, Lievre A, Lombardi P, De Luca E, Vernerey D, Sperti E, Musettini G, Satolli MA, Edeline J, Spadi R, Neuzillet C, Falcone A, Pasquini G, Clerico M, Passardi A, Buscaglia P, Meurisse A, Aglietta M, Brac C, Vasile E, Montagnani F. Validated Nomogram Predicting 6-Month Survival in Pancreatic Cancer Patients Receiving First-Line 5-Fluorouracil, Oxaliplatin, and Irinotecan. Clin Colorectal Cancer. 2019 Dec;18(4):e394-e401. doi: 10.1016/j.clcc.2019.08.004. Epub 2019 Sep 4.

    PMID: 31564556DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

folfirinox

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Lorenzo Fornaro, MD

    Azienda Ospedaliero, Universitaria Pisana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Alfredo Falcone

Study Record Dates

First Submitted

July 6, 2018

First Posted

July 18, 2018

Study Start

October 2, 2017

Primary Completion

January 18, 2018

Study Completion

June 30, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(7)